Who manufactures Copiktra (Duvelisib)?

Duvelisib bulk supplier for pharma manufacturers

Duvelisib 15mg, 25mg Suppliers & Bulk Manufacturers

Available Forms: Capsules

Available Strengths: 15mg, 25mg

Reference Brands: Copiktra (USA/EU)

Duvelisib is an oral phosphoinositide 3-kinase (PI3K) inhibitor used to treat adults with relapsed or refractory chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and follicular lymphoma (FL). It works by blocking PI3K-delta and PI3K-gamma enzymes, which play key roles in cancer cell survival and proliferation. Copiktra helps slow the growth of malignant cells and reduce tumor progression.

Ask About Access

Usually answered within 48 hours | GMP documents shared before you commit

Manufacture or export Duvelisib? List it or send an offer →

Product Description:

Duvelisib inhibits both the delta and gamma isoforms of phosphoinositide 3-kinase. The delta isoform sustains survival signalling within the malignant B cell itself; the gamma isoform operates in the surrounding microenvironment, in the T cells and macrophages that a lymphoid tumour recruits to protect itself. Targeting both is intended to remove the cell's own survival signal and the supportive niche at the same time.

It is taken orally for relapsed or refractory chronic lymphocytic leukaemia and small lymphocytic lymphoma after at least two prior therapies. The adverse effect profile is dominated by immune-mediated events that appear after months rather than weeks: severe diarrhoea and colitis, cutaneous reactions, pneumonitis and hepatotoxicity, alongside serious infection including Pneumocystis and cytomegalovirus. Prophylaxis and CMV monitoring are required, and prompt interruption at the first sign of colitis is essential.

Sourcing notes. Originator product, on patent. As with other drugs in the PI3K class, regulatory reassessment of the benefit-risk balance has narrowed the approved indication in several markets and withdrawn it in others, so registration status must be confirmed per destination before quoting. Oral capsules in two strengths; room temperature storage.

How Duvelisib is supplied today, and licensing ahead of patent expiry

Duvelisib is a patented innovator medicine. Where its patents are in force, which today includes most major markets, it can only be supplied by the originator or its licensees, through the routes below. Patents do expire, though, and generic development and licensing deals for post-patent markets start years in advance. If you are developing Duvelisib, hold a dossier for it or want to license it, talk to us.

Named-patient import Where a patient needs the product in a market where it is not registered, named-patient import is the lawful route. It requires the treating physician's documentation and authorisation from the destination regulator. We handle this pathway. Named-patient access

Authorised distribution For registered markets, supply runs through the manufacturer's authorised distribution channel. We can identify the authorised route for your market and tell you whether the product is registered there at all. Innovator sourcing

A genericised alternative Where the clinical requirement is the drug class rather than this specific molecule, there is often an off-patent alternative that is faster to register and materially cheaper. Tell us the indication and target market and we will say plainly whether one exists. Discuss alternatives

Licensing and generic development Patents expire country by country, and in many countries development and dossier filing can start before expiry under research and regulatory-review exemptions. We connect manufacturers developing this molecule, dossier holders, licensees and tech-transfer partners for markets where it is, or will become, off-patent. Partner on this molecule

Ask about Duvelisib supply →

Back to Listing

Frequently Asked Questions

Copiktra (Duvelisib) is developed and sold by Secura Bio. PharmaTradz handles enquiries for authorised supply of the originator product, named-patient import where it is not registered, and licensing or development work ahead of patent expiry.